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A Hinge Flap as an Additional Layer to Reinforce the Buccal Advancement Flap for Treating Chronic Oroantral Fistulae (COAF) in the Most Posterior Aspect of the Maxilla"
Sponsor study identifier
interventional
40
1 country
1
Study Start
April 1, 2023
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Background The chronic oroantral fistulas (COAF) is an epithelized communication that is formed between the squamous epithelium of the oral cavity and the pseudo-stratified columnar ciliated epithelium of the maxillary sinus with a high recurrent rate. The use of palatal flaps has been documented for treating such fistulae. The presence of the oroantral fistula at the area of second molars or maxillary tuberosity could complicate the use of the palatal rotational flap where the arch of its rotation is increased leading to compromised blood supply. The use of the buccal flap is not advocated because it is very thin. Rationale Double or triple-layer closure is indicated to avoid recurrence of the COAF. Different layers have been documented to minimize the risk of recurrence and reinforce buccal flaps. The oral tissues at the oral side of the oroantral fistula could used as an additional layer with buccal advancement flap and buccal fat to omit the use of palatal flap with its subsequent problems in the most posterior aspect of the maxilla Study objectives Therefore, this study will be conducted to evaluate the use of hinge flaps to reinforce the buccal advancement flap for surgical closure of the COAF in the most posterior area of the maxilla Methods The hinge flap will be performed at the oral side of the COAF to close the perforation in the sinus membrane. The oral side of the COAF will be closed with buccal advancement flap. The success rate, recurrence, time of surgery, postoperative complications, will be evaluated.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2023
Actual (reported)April 24, 2023
Actual (reported)October 4, 2023
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Duration of Surgery
The time elapsed from the initial incision to final closure of the flap. The time will be calculated in minutes. The mean and standard deviation will be then calculated and used to compare between the study's arms.A prolonged time means worse outcomes
30 minutes
Difficulties during surgeries
Surgical difficulties scoring system will be used.Surgical difficulty was assessed by the operator using an index of 1-10 with the following divisions: 1-3 low difficulty, 4-6 intermediate difficulty, and 7-10 high difficulty. A low difficulty score means a better outcome
60 minutes
Recurrence of the Oroantral fistula
The patients will be followed after surgery for the success or failure of the surgical closure. The follow-up will be weekly in the first month, and then monthly in the next three months.The recurrence means worse outcomes
At the end of the postoperative fourth month
Patients' satisfaction
At the end of the fourth month after surgery
Patients who will be included in this study will be treated by using hinge flap and buccal advancement flap to close their oroantral fistula. A circular incision will be performed at the oral side of the oroantral fistula. The tissues will be reflected and sutured by purse sutures. Then the tissues will be pushed up to close sinus membrane. A pyramidal flap will be reflected at the buccal tissues, then horizontal incisions will be performed at the base of the flap to allow advancement of the flap over the fistula and a tension-free suturing to the palatal tissues.
Patients who will be included in this study will be treated by using he anteriorly based palatal rotational flap to close the oroantral fistula. Two paralleling incisions will be performed on the palatal side of the fistula. The distance between the two incisions will be 2 to 3 mm greater than the width of the fistula. Then the two incisions will be connected together via a circular incision at the bony end of the hard palate. The flap reflection will be performed, and the greater palatine vessels will be legated and cauterized to allow lateral repositioning of the flap over the fistula. The flap will be sutured to the buccal tissues.
The hinge flap is raised via circular incision around the oral side of the oroantral fistula then sutured with purse suture to close the sinus membrane perforation and it is used as an additional layer that reinforce the buccal advancement flap
College of Dentistry, Qassim University
Buraidah, Al-Qassim Region, 1162, Saudi Arabia
Ghada A khalifa, Professor
Department of Maxillofacial Study and Diagnostic Sciences, College of Dentistry, Qassim University
First Submitted
April 24, 2023
First Posted
October 4, 2023
Study Start
April 1, 2023
Actual (reported)Primary Completion
December 31, 2026
Two paralleling incisions will be performed on the palatal side of the fistula. The distance between the two incisions will be 2 to 3 mm greater than the width of the fistula. Then the two incisions will be connected together via a circular incision at the bony end of the hard palate. The flap reflection will be performed, and the greater palatine vessels will be legated and cauterized to allow lateral repositioning of the flap over the fistula. The flap will be sutured to the buccal tissues.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 9, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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